Aptevo Therapeutics Announces First Complete Remission in Ongoing APVO436 Phase 1 Clinical Trial
Aptevo Therapeutics announced significant progress in its ongoing APVO436 Phase 1 clinical trial for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). A patient in cohort 6 achieved complete remission, with bone marrow blasts decreasing from 29% to 0% after two cycles of treatment. As dosing continues in cohort 7, pharmacokinetic modeling suggests dosing in cohorts 5-8 may yield further clinical responses. Aptevo’s ADAPTIR™ technology is highlighted as a more convenient and cost-effective option compared to traditional CAR-T therapies.
- Complete remission observed in a patient from cohort 6 of APVO436 clinical trial.
- Bone marrow blasts decreased from 29% at screening to 0% after two treatment cycles.
- Pharmacokinetic modeling indicates favorable dosing ranges that could lead to further clinical activity.
- None.
First Complete Remission Observed in a Patient in Cohort 6
Dosing Continues in Cohort 7
SEATTLE, WA / ACCESSWIRE / November 3, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ platform, today provided an update on its ongoing APVO436 Phase 1 clinical trial.
APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile.
Aptevo is pleased to announce that, based on preliminary data, a patient in cohort 6 of the clinical trial has shown complete remission.
In summary:
- Patient bone marrow blasts decreased from
29% at screen to6% after the first cycle of treatment, and to0% after the second cycle of treatment; and, - The patient's platelet count and absolute neutrophil count (ANC) met complete remission criteria (CR).
"We are greatly encouraged by the complete remission in the patient in cohort 6, which is a wonderful outcome for them," said Marvin White, President and CEO of Aptevo Therapeutics. "We are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," concluded Mr. White.
APVO436 was built on Aptevo's next generation proprietary ADAPTIR™ protein therapeutic platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer the ADAPTIR™ platform offers key advantages over other bispecific formats, derived in part from the flexible and modular nature of the ADAPTIR™ structure.
Aptevo believes that its differentiated ADAPTIR™ bispecific technology platform has the potential to offer a more convenient and cost-effective solution compared to other immunotherapies such as CAR-T therapies. While CAR-T therapies have proven effective in generating robust and durable treatment responses, they remain challenging and expensive to manufacture and administer to patients. In contrast, bispecific technologies may represent a simpler, more competitive ‘off-the-shelf' solution in the rapidly advancing field of cancer immunotherapy.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. The Company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603, were developed based on the Company's versatile and robust ADAPTIR™ modular protein technology platform. The ADAPTIR™ platform is capable of generating highly differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, please visit www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential royalty and milestone payments, Aptevo's ability to successfully obtain revenue on terms acceptable to Aptevo, Aptevo's outlook, financial performance or financial condition, estimated cash burn, Aptevo's technology and related pipeline, collaboration and partnership opportunities, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates," "will" and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the initiation and enrollment of future clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19). Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 25, 2020 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement.
Contact Information:
Aptevo Therapeutics
Elif McDonald
Senior Director, Investor Relations and Corporate Communications
Direct: (206) 859-6616
Email: mcdonalde@apvo.com
SOURCE: Aptevo Therapeutics
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